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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

When you hear the term "adverse reaction" in the life sciences industry, you're likely to immediately think about pharmaceutical or medical device products. But as a new guidance document from the US Food and Drug Administration (FDA) makes clear, cellular and tissue products are also subject to reporting requirements.

Background

The new draft guidance document relates to human cells, tissues and cellular and tissue-based products—better known by their acronym, HCT/Ps. The products are somewhat unusual in that they are regulated under the Public Health Service Act (PHS, Section 361), and not the Federal Food, Drug and Cosmetic Act (FD&C Act), which is the backbone of most healthcare product regulation in the US.

It's also worth noting which products are covered under FDA's HCT/P regulations, and which are not. For example, whole organs aren't covered by the regulations, and aren't even overseen by FDA. Likewise, "minimally manipulated bone marrow," blood products and secretions (e.g. breast milk) aren't covered under the regulations.

That leaves just about every other tissue or cellular product covered, however. According to FDA regulations at 21 CFR 1271.3(d), the agency regulates most donated materials (aside from whole organs) from deceased donors, as well as cells, cord blood, and reproductive cells and tissues from living donors.

In other words, if it's "intended for implantation, transplantation, infusion, or transfer into a human recipient," and isn't on a short list of exempt products, FDA probably regulates it as an HCT/P.

Guidance Details

"All non-reproductive 361 HCT/Ps are subject to the adverse reaction reporting requirements under §1271.350(a)," the agency explains in the guidance. For example, donated cartilage, ligaments, skin, tendons, heart valves and fascia all fall under the scope of FDA's reporting guidelines.

So which events need to be reported to FDA under its reporting requirements? FDA says any adverse reaction involving a "communicable disease" must be reported, as should any fatal or life-threatening event, or an event which caused "permanent impairment" or one which "necessitates medical or surgical intervention, including hospitalization."

The establishment which makes the product available for distribution must report the event, FDA said.

Reports must be made within 15 days of the establishment becoming aware of the event, and should include information regarding the symptoms and outcome of the reaction, the recipient's medical history, relevant test results and a history of the patient's other transfusions/infusions/implants/transfers "that may have been a source for communicable disease transmission." Form 3500A should be used.

The guidance also includes extensive information regarding the information each manufacturer should review prior to submitting an adverse event report, including processing information, environmental information (e.g. storage conditions), tracking information related to other products, and whether the product labeling is still appropriate.

The draft guidance is intended to supersede a similar guidance issued in 2005, FDA said in an accompanying Federal Register announcement.